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Not Yet Recruiting NCT07895433

Rifaximin for Prevention of Recurrent Mild-to-moderate Ascending Cholangitis After Biliary-enteric Anastomosis

Conditions: Cholangitis, Ascending Cholangitis

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 60
Sponsor: Ruijin Hospital

Summary

This single-center prospective randomized controlled trial plans to recruit 60 adult patients with recurrent ascending cholangitis after biliary-enteric anastomosis. Subjects will be randomized 1:1 to the intervention group or control group. The control group receives standard treatment. The intervention group takes rifaximin tablets together with standard treatment for 3 months. Participants will be followed for 3 months. The primary outcome is the number of recurrent biliary infections. Gut microbiota changes and adverse events will also be evaluated. This open-label study explores whether rifaximin can lower the recurrence risk of cholangitis after biliary-enteric anastomosis.

Eligibility Criteria

Inclusion Criteria: 1. Patients who have undergone biliary-enteric anastomosis. 2. History of mid-to-moderate ascending cholangitis. 3. Acute cholangitis prior to enrollment is well-controlled; intravenous antibiotics have been withheld for at least 1 week, with normalized body temperature, white blood cell count and C-reactive protein (CRP). 4. Age between 18 and 80 years, inclusive, with no gender restriction. 5. The patient or their legal guardian voluntarily signs the informed consent form. Exclusion Criteria: 1. Patients with concomitant severe acute cholangitis (TG18 Grade III), septic shock, or those assessed to require emergency biliary drainage (ERCP/PTCD). 2. Patients with biliary obstruction confirmed by imaging or endoscopy (such as impacted stones, tumor compression, anastomotic stricture, etc.). 3. Patients with known allergy to rifaximin or rifamycin-class agents. 4. Patients with severe hepatic dysfunction (Child-Pugh class C) or severe renal insufficiency (eGFR \< 30 mL/min/1.73 m²). 5. Pregnant or breastfeeding women. 6. Patients with other active, uncontrolled systemic infections. 7. Patients who received continuous rifaximin treatment for more than 7 days within 3 months prior to enrollment. 8. Patients with inflammatory bowel disease, celiac disease, short bowel syndrome, or other diseases that substantially alter gut microbiota or drug absorption. 9. Patients with unresected primary malignancy, recurrent or metastatic tumor, or those receiving chemotherapy, radiotherapy, or immunotherapy. 10. Patients with severe coagulation dysfunction (INR \> 2.0 and not correctable). 11. Patients with psychiatric disorders, cognitive impairment, or a history of substance abuse that may compromise adherence to the study protocol.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07895433). StuddyBuddy aggregates publicly available trial information.